- Directly supervises the quality control associates, monitor individual skills, technique and abilities for most efficient operation.
- To follow progress of work; anticipate or investigate delays or inadequate performance by taking corrective action within limits of established practice and aid other departments as needed.
- Provides on the floor and technical support to quality control associates with guidance and improve the quality system, regulatory policies and procedures.
Drive QC Operation and Laboratory Operational Excellence
- Support and enforce the quality management system related to QC, regulatory policies and work instructions.
- SAP account holder for method creation, support QC data input and release, inspection plans and reports creation to ensure the process flow is smooth.
- Oversee quality and quantity of all QC laboratory output and testing timelines by monitoring testing duration, arrange for equipment, materials and supplies to be available for QC testing
- Oversee that equipment is given proper care; troubleshoot faulty operations to determine cause and arrange for required repair and maintenance which could affect operational testing needs
Drive continuous QC training and development
- Provide or arranges for training and cross training to employees in the performance of duties by assisting and instruct personnel as necessary to insure proper flow of work through department.
- Provide guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.
Maintain QC Document Control and lead in investigation
- Review and approval of controlled Quality Control documents including but not limited to specifications, procedures, work instructions, validation protocols, equipment software audit trials, stability worksheets, data integrity logs and validation reports.
- Ensure department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.
- Performs investigations for laboratory out of specification (OOS), out of trend (OOT) questionable results, quality event, CAPA and complaint related to testing, safety related incidents and/or processes related to the QC laboratory.
Maintain Quality, Regulatory and Safety Compliance
- Understands regulatory requirements for 21 CFR 820, ISO 17025, EXCiPACT, GLP, GMP including USP/EP/BP/JP/ChP general practices and procedures.
- Proactively maintains current industry and regulatory knowledge for medical devices, ISO 17025, GMP principles and current analytical methodology.
- Enforce prescribed local safety rules and regulations related to QC laboratory; insure that work areas are maintained in a neat and orderly condition in the work environment; to perform safety and security procedures to open and close buildings and facilities.
Customer Centric
- Work with external customers, regulatory agents and vendors during audits and site visits.
- Work and collaborate with internal stakeholders to insure successful visits and audits
QC Decision Making for Operation
- Assist in determining priority of urgent items and appropriate action plan to effectuate priority.
- Drive all QC decision making in approve rejections and rework actions as recommended by Quality Control Technicians.
Additional Assignments
- Performs other duties and ad-hoc projects as assigned to drive growth, operational excellence and organization goals.
